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Study on the Safety and Effectiveness of Fostemsavir for Patients with Multi-drug Resistant HIV-1 Who Have Had Extensive Previous Treatments

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What is this study about?

This clinical trial is focused on studying a treatment for people living with HIV-1, a virus that attacks the immune system. The study is specifically for individuals who have been heavily treated in the past and have developed resistance to multiple drugs. The treatment being tested is called fostemsavir, which is also known by its code name BMS-663068 or GSK3684934. Fostemsavir is taken in the form of prolonged-release tablets, which means the medication is released slowly into the body over time.

The purpose of the study is to investigate the safety and effectiveness of fostemsavir in people whose current HIV treatments are no longer working effectively. Participants in the study will receive either fostemsavir or a placebo, in addition to their existing treatment regimen. The study will monitor changes in the amount of HIV in the blood and other health indicators over a period of time, including up to 96 weeks.

Throughout the study, participants will have regular check-ups to assess their health and the impact of the treatment. The study aims to provide valuable information on how fostemsavir can help manage HIV-1 in patients who have limited treatment options due to drug resistance. This research is important for developing new strategies to improve the lives of people living with HIV-1.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A blood test is performed to measure the level of HIV-1 RNA in the blood. This test helps determine the current viral load.

2 randomization and treatment initiation

Participants are randomly assigned to receive either the study medication, fostemsavir, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

The study medication, Rukobia 600 mg prolonged-release tablets, is taken orally. The dosage is one tablet twice daily.

3 treatment period

The treatment period involves regular intake of the assigned medication. Participants continue their existing antiretroviral regimen alongside the study medication.

Regular follow-up visits are scheduled to monitor health status, side effects, and the effectiveness of the treatment. Blood tests are conducted to measure changes in HIV-1 RNA levels and CD4+ T-cell counts.

4 evaluation of treatment efficacy

The primary evaluation occurs on Day 8, where the change in HIV-1 RNA levels from the start of the study is assessed.

Secondary evaluations are conducted at Weeks 24, 48, and 96 to assess the durability of the response and monitor any adverse events or disease progression.

5 completion of study participation

Upon completion of the study, a final assessment is conducted to evaluate overall health and the long-term effects of the treatment.

Participants are provided with information on continuing care and any necessary follow-up actions.

Who Can Join the Study?

  • You must sign a written consent form to participate.
  • The study is for men and non-pregnant women who have a long-term infection with HIV-1.
  • You need to be 18 years or older.
  • If you have been in the study before but left before starting treatment, you might be able to join again. You will need to sign the consent form again and go through the screening process once more.
  • You should have experience with antiretroviral treatments, which are medicines used to treat HIV, and have shown resistance or intolerance to at least three different types of these medicines.
  • Your current HIV treatment should not be working well, with a confirmed HIV-1 RNA level of 400 or more. This is a measure of the virus in your blood.
  • You must have at least one fully effective medicine available in one or two classes of antiretroviral drugs, considering any past resistance or safety concerns.
  • If you are a woman who can have children, you must have a negative pregnancy test before starting the study drug.
  • Women must not be breastfeeding during the study.
  • Women who can have children must agree to use approved birth control methods during the study and for at least 60 hours after the last dose of the study drug.
  • Men who are sexually active with women who can have children must use condoms and agree to use birth control methods during the study and for at least 60 hours after the last dose of the study drug.
  • Women who are not sexually active with men do not need to use birth control but still need to take pregnancy tests as required by the study.

Who Cannot Join the Study?

  • Patients who have not been heavily treated for their HIV infection.
  • Patients who are not infected with a type of HIV that is resistant to multiple drugs. Multi-drug Resistant (MDR) means the virus does not respond to several different medications.
  • Patients who are not experiencing a failing treatment regimen. A failing regimen means the current treatment is not effectively controlling the virus.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of a vulnerable population. A vulnerable population includes groups who may have additional risks or needs, such as children, pregnant women, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Romania Romania
Not recruiting
01.09.2015

Trial locations

Investigated drugs:

Fostemsavir is a medication being studied for its effectiveness and safety in people with HIV-1 who have tried many other treatments without success. It works by blocking the virus from entering human cells, which helps to reduce the amount of virus in the body. This study aims to see how well fostemsavir works compared to a placebo in reducing the levels of HIV-1 in the blood.

HIV-1 Infection with Multi-drug Resistance – This condition occurs when the human immunodeficiency virus type 1 (HIV-1) becomes resistant to multiple antiretroviral drugs, making it difficult to control the virus with standard treatments. The virus continues to replicate despite the use of several classes of antiretroviral medications. Over time, this can lead to a decrease in the effectiveness of the immune system, as the virus targets and destroys CD4+ T-cells, which are crucial for immune function. Individuals with this condition may experience a higher viral load and a decrease in CD4+ cell counts. The progression of the disease can vary, but it often involves ongoing challenges in managing the infection due to limited treatment options.

Trial ID:
2024-513930-39-00
Protocol code:
205888
NCT ID:
NCT02362503
Trial Phase:
Therapeutic confirmatory (Phase III)

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